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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K150572
FOIA Releasable 510(k) K150572
Device Name Respire Pink Series-Herbst-EF
Applicant
Respire Medical Holding
18 Bridge St., Suite 4j
Brooklyn,  NY  11201
Applicant Contact David Walton
Correspondent
Quality Solutions and Support, LLC
P.O. Box 8271
Holland,  MI  49422
Correspondent Contact Stephen W Inglese
Regulation Number872.5570
Classification Product Code
LRK  
Date Received03/06/2015
Decision Date 08/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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